Amrix
Approved
Approval ID
b8ca1d80-6ea9-4a3f-ab06-beedf845de8f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 18, 2011
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cyclobenzaprine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-596
Application NumberNDA021777
Product Classification
M
Marketing Category
C73594
G
Generic Name
Cyclobenzaprine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 18, 2011
FDA Product Classification
INGREDIENTS (10)
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
CYCLOBENZAPRINE HYDROCHLORIDEActive
Quantity: 15 mg in 1 1
Code: 0VE05JYS2P
Classification: ACTIM
DIETHYL PHTHALATEInactive
Code: UF064M00AF
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
Cyclobenzaprine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-810
Application NumberNDA021777
Product Classification
M
Marketing Category
C73594
G
Generic Name
Cyclobenzaprine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 18, 2011
FDA Product Classification
INGREDIENTS (11)
CYCLOBENZAPRINE HYDROCHLORIDEActive
Quantity: 30 mg in 1 1
Code: 0VE05JYS2P
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
DIETHYL PHTHALATEInactive
Code: UF064M00AF
Classification: IACT
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4B
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT